Brain TumorNCT05356507
The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach
An observational study of Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care. The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Tumor
- What is being tested?
- Patient population
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2022to 31 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a diagnosis of primary or metastatic brain tumors who are scheduled to undergo surgical interventions
Who may be able to join
- Outpatients at MDACC who are 18 years or older;
- Are being/have been seen at the MD Anderson Neurosurgery clinic;
- Have a diagnosis of a primary or metastatic intracranial or skull-based brain, pituitary, or meningeal lesions;
- Are scheduled to undergo surgical intervention.
Who cannot join
- Have preferred language listed other than English on the chart;
- Present with cognitive functional impairment, evidence of expressive or receptive aphasia, or gross dysfunction limiting memory or ability to complete a self-report questionnaire, which will be determined by reviewing provider's notes;
- Refusal to participate in research.
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.
The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.
Read the detailed description
The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.
The primary objective of this study is:
To examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.
This study will address the following secondary objectives:
- To examine bivariate relationships between SB, PsD, and SN.
- To explore effects of patients' spirituality on the relationship between patients' SN and SWB.
This study is not powered to test hypotheses concerning the secondary objectives but will specifically examine through descriptive statistics and confidence intervals the following:
- SN, PsD, and SB are positively correlated with each other.
- SN negatively influences SWB.
- SN positively influences spirituality.
- Spirituality positively influences SWB.
- Conditions
- Brain Tumor
- Being tested
- Patient population
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient populationOther
Questionnaires, standard of care
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the Spiritual Needs on Spiritual Well-Being in Patients with Brain Tumors, utilizing the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB).
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2022
- Study start29 Aug 2022
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Why it stopped: 0 accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anecita Fadol, BLS, MSN, PHD, RN, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05356507
- Sponsor's protocol ID
- 2020-0878
- Other IDs
- NCI-2021-12910
- Status last verified
- Jan 2023
- First submitted
- 11 Apr 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spiritual Needs on Spiritual Well-Being in Patients With Brain Tumors: A Structural Equation Modeling Approach
- ClinicalTrials.gov ID
- NCT05356507
- Acronym / sponsor ID
- 2020-0878
- Conditions
- Brain Tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: 0 accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 29 Aug 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 2 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.
The primary objective of this study is to examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.
Detailed description
The aim of this study is to describe a patient's Spiritual Needs and related factors that contribute to a patient's Spiritual Well-Being in the context of perioperative care.
The primary objective of this study is:
To examine the fit of the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB) and explain how SWB is affected by Symptom Burden (SB), Psychological Distress (PsD), and Spiritual Needs (SN) reported by the patients with brain tumors before having surgery.
This study will address the following secondary objectives:
- To examine bivariate relationships between SB, PsD, and SN.
- To explore effects of patients' spirituality on the relationship between patients' SN and SWB.
This study is not powered to test hypotheses concerning the secondary objectives but will specifically examine through descriptive statistics and confidence intervals the following:
- SN, PsD, and SB are positively correlated with each other.
- SN negatively influences SWB.
- SN positively influences spirituality.
- Spirituality positively influences SWB.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a diagnosis of primary or metastatic brain tumors who are scheduled to undergo surgical interventions
Key inclusion criteria (4 listed)
- Outpatients at MDACC who are 18 years or older;
- Are being/have been seen at the MD Anderson Neurosurgery clinic;
- Have a diagnosis of a primary or metastatic intracranial or skull-based brain, pituitary, or meningeal lesions;
- Are scheduled to undergo surgical intervention.
Key exclusion criteria (3 listed)
- Have preferred language listed other than English on the chart;
- Present with cognitive functional impairment, evidence of expressive or receptive aphasia, or gross dysfunction limiting memory or ability to complete a self-report questionnaire, which will be determined by reviewing provider's notes;
- Refusal to participate in research.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient populationQuestionnaires, standard of care | Other | – |
Primary outcome
To evaluate the Spiritual Needs on Spiritual Well-Being in Patients with Brain Tumors, utilizing the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB).
Time frame: Through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- M D Anderson Cancer CenterLink provided by the sponsor.
Related trials for Brain Tumor
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anecita Fadol, BLS, MSN, PHD, RN principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumor, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the Spiritual Needs on Spiritual Well-Being in Patients with Brain Tumors, utilizing the Structural Equation Model (SEM) of the theory on Spiritual Well-Being (SWB). (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.